BEUDAMED
    FDA Enforcement Class II Terminated

    9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design M Malar Sizer Set (Silicone, Non-Sterile) 9952 Extended Contoured, Malar Sizer Set (Silicone, Non-Sterile) 85000 Petite Nasal Dorsum Sizer Set (Silicone, Non-Sterile) Accessories to Medpor Implants

    Recall: Z-1150-2017 · Reported February 15, 2017

    Enforcement

    Recall Number
    Z-1150-2017
    Event ID
    76146
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Leibinger GmbH & Co. KG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 15, 2017
    Initiation Date
    January 3, 2017
    Classification Date
    February 8, 2017
    Termination Date
    July 27, 2017
    Address
    Botzinger Strasse 41, N/A, Freiburg, N/A, N/A, Germany

    Description

    9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design M Malar Sizer Set (Silicone, Non-Sterile) 9952 Extended Contoured, Malar Sizer Set (Silicone, Non-Sterile) 85000 Petite Nasal Dorsum Sizer Set (Silicone, Non-Sterile) Accessories to Medpor Implants

    Reason

    An incorrect sterility status on the label, non-sterile products labeled as sterile

    Code Info

    9805 Orbital Volume Sizer Set with Tray (Non-sterile) Lot M1311023 9951 Design M Malar Sizer Set (Silicone, Non-Sterile) Lot M1305001 9952 Extended Contoured, Malar Sizer Set (Silicone, Non-Sterile) Lot M1603004 85000 Petite Nasal Dorsum Sizer Set (Silicone, Non-Sterile) Lot M1603003

    Distribution

    Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia, Canada, Chile, Spain, South Africa and Taiwan.

    Quantity

    619